MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX L/P; SURGICAL MESH

Catalog Number	0144680
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Disability (2371)
Date of Event	09/17/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence and adhesions are an inherent risk of surgery and is listed in the instructions-for-use a possible complication.The attorney alleges removal of the device, however no medical records have been provided.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2012: the patient underwent repair of a ventral hernia.A bard/davol composix l/p hernia mesh 6.2" x 6.8", lot number huvh1102 was implanted in the patient during this repair.(b)(6) 2014: the patient underwent surgery due to chronic abdominal wall pain.During the surgery, the surgeon noted, "severe intra-abdominal adhesions, mesh ingrowth into liver." the composix l/p implanted in plaintiff failed to reasonably perform as intended.The product caused serious injury and had to be surgically removed via invasive surgery,necessitating additional invasive surgery to repair the hernia that the product had initially been implanted to treat.The patient continues to experience complications related to the bard/davol composix l/p.The patient will likely require additional surgeries to repair the damage from the product.The bard/davol composix l/p caused serious injury and had to be surgically removed via invasive surgery, necessitating additional invasive surgery to repair the hernia that the product had initially been implanted to treat.It is alleged that the bard/davol composix l/p is defective.The attorney alleges the patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.

• Brand Name: COMPOSIX L/P
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7939570
• Report Number: 1213643-2018-03436
• Device Sequence Number: 11125244
• Product Code: FTL
• UDI-Device Identifier: 00801741031359
• UDI-Public: (01)00801741031359
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2012
• Device Catalogue Number: 0144680
• Device Lot Number: HUVH1102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability